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Prospective Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With Reduced Pulmonary Capacity

Primary Purpose

Respiration Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Fast track lung surgery
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiration Disorders focused on measuring lung resection, reduced pulmonary function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • resection of the lung
  • FEV1 <70% of expected value or below 1.5L
  • 18-80y
  • given written informed consent

Exclusion Criteria:

  • contraindication for epidural anesthesia
  • prio ipsilateral thoracotomy
  • chemotherapy <6 weeks prior to study enter
  • existing pneumonia (fever, elevated WCC, elevated CRP)

Sites / Locations

  • University of UlmRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

conventional perioperative management for lung surgery

fast track management for lung surgery

Outcomes

Primary Outcome Measures

pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality

Secondary Outcome Measures

duration of ICU treatment

Full Information

First Posted
September 13, 2007
Last Updated
February 1, 2008
Sponsor
University of Ulm
Collaborators
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT00530491
Brief Title
Prospective Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With Reduced Pulmonary Capacity
Official Title
Prospective Randomized Controlled Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With FEV1 < 70% of Expected Value or < 1.5L
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2008 (Anticipated)
Study Completion Date
October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Ulm
Collaborators
Heidelberg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A fast track recovery program (thoracic epidural anesthesia, carbohydrate drink preoperative, early removal of chest tubes) is evaluated compared to conventional perioperative treatment (patient controlled analgesia, no carbohydrate drink preoperative) in patients with FEV1 < 70% of expected value or < 1.5L who undergo resections of the lung.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration Disorders
Keywords
lung resection, reduced pulmonary function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
conventional perioperative management for lung surgery
Arm Title
2
Arm Type
Experimental
Arm Description
fast track management for lung surgery
Intervention Type
Procedure
Intervention Name(s)
Fast track lung surgery
Intervention Description
fast track lung surgery: carbohydrate drink preoperatively, PCEA, early removal of chest tube conventional: no carbohydrate drink preoperatively, ICB+PCA, removal of chest tube depending upon chest x-ray
Primary Outcome Measure Information:
Title
pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality
Time Frame
1 year
Secondary Outcome Measure Information:
Title
duration of ICU treatment
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: resection of the lung FEV1 <70% of expected value or below 1.5L 18-80y given written informed consent Exclusion Criteria: contraindication for epidural anesthesia prio ipsilateral thoracotomy chemotherapy <6 weeks prior to study enter existing pneumonia (fever, elevated WCC, elevated CRP)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernd M Muehling, M.D.
Phone
+49-731-500
Ext
54044
Email
bernd.muehling@uniklinik-ulm.de
First Name & Middle Initial & Last Name or Official Title & Degree
Karl-Heinz Orend, M.D., Ph.D.
Phone
+49-731-500
Ext
54005
Email
karl-heinz.orend@uniklinik-ulm.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd M Muehling, M.D.
Official's Role
Study Chair
Facility Information:
Facility Name
University of Ulm
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernd M Muehling, M.D.
Phone
+49-731-500
Ext
54055
Email
bernd.muehling@uniklinik-ulm.de
First Name & Middle Initial & Last Name & Degree
Alexander Oberhuber, M.D.
Phone
+49-731-500
Ext
54058
Email
alexander.oberhuber@uniklinik-ulm.de
First Name & Middle Initial & Last Name & Degree
Bernd M Muheling, M.D.

12. IPD Sharing Statement

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Prospective Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With Reduced Pulmonary Capacity

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